Events

Recall of Device Recall TRx Vertical Positioner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Motion Concepts.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69113
  • Event Risk Class
    Class 2
  • Event Number
    Z-2657-2014
  • Event Initiated Date
    2014-08-28
  • Event Date Posted
    2014-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129660
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, powered - Product Code ITI
  • Reason
    Motion concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the vertical position system (trx vertical positioner).
  • Action
    URGENT RECALL NOTIFICATION Letters (dated 8/26/2014) were sent to customers on 8/26/14 via Federal Express. Motion Concepts is requesting that all customers that have purchased a Motion Concepts TRx Vertical Positioner system in between June 2011 - May 2014 to make arrangements for replacement of the knee support mount in accordance with the instructions enclosed in the letter. For questions, please contact us at 905-695-0134.

Device

Device Recall TRx Vertical Positioner
  • Model / Serial
    All units manufactured between June 2011 and May 2014: Serial Numbers 28583, 28597, 28604, 28607, 28629, 30334, 028380, U001050, U001083, U001544, U002020, U002326, U002386, U002403, U002411, U002489, U002502, U002505, U002509, U002510, U002519, U002716, U002922, U003577, U004011, U004018, U004073, U004079, U004145, U004214, U004400, U004404, U004472, U004485, U006042, U006234, U006235, U006260, U006295, U006296, U006353, U006378, U007126, U007138, U007163, U007239, U007245, U007279, U007288, U007407, U008556, U008631, U008698, U008840, U008896, U009548, U009569, U009579, U009707, U009718.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.
  • Product Description
    TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
  • Manufacturer
    Motion Concepts

Manufacturer

Motion Concepts
  • Manufacturer Address
    Motion Concepts, 84 Citation Drive, Units 1-7, Concord Canada
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA